Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

Completed

Conditions studied: Breast Cancer

In brief

This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.

Key facts

Study ID

NCT00619762

Run by

LifeCell

People needed

17

Starts

2007-10-01

Expected to finish

2009-12-01

Last updated by the study team

2016-11-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy
• An ASA Physical Status Classification5 of 1 or 2 (see App I)
• Estimated life expectancy > 1 year

You may not qualify if…

• Clinically significant systemic disease
• Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time
• Predicted excised breast mass of >750 gms
• Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection
• Need for tissue flap in addition to expander
• History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
• Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
• Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Chicago, Illinois, United States
• Study site — Great Neck, New York, United States
• Study site — Willow Grove, Pennsylvania, United States
• Study site — McLean, Virginia, United States

Full record on ClinicalTrials.gov

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